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Phase 3 Trial of Lemtrada for Multiple Sclerosis

Sanofi and Genzyme announced positive results from CARE-MS I, a randomized, Phase 3 clinical trial comparing Lemtrada (alemtuzumab) to Rebif (high dose subcutaneous interferon beta-1a; EMD Serono) in patients with relapsing-remitting multiple sclerosis (MS). New data show that 78% of patients treated with Lemtrada remained relapse-free for two years, providing statistically significant improvement over Rebif (78% vs. 59% at two years, P<0.0001) and meeting this secondary endpoint.

Lemtrada is a humanized monoclonal antibody being studied as a potential therapy for relapsing MS. Alemtuzumab targets the cell-surface glycoprotein CD52, which is highly expressed on T- and B-lymphocytes. Preliminary research suggests that alemtuzumab initially depletes the T- and B-cells that may be responsible for the cellular damage in MS. This depletion of T- and B-cells is followed by a distinctive pattern of lymphocyte repopulation. Alemtuzumab appears to have little or no effect on other cells of the immune system. In addition to the completed CARE-MS I study, another Phase III trial, CARE-MS II, will evaluate alemtuzumab against interferon beta-1a in relapsing-remitting MS patients who have relapsed while on therapy.